UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044115 |
|---|---|
| Receipt number | R000050367 |
| Scientific Title | Observation study of continuous glucose monitoring for postoperative patients in esophageal cancer |
| Date of disclosure of the study information | 2021/05/06 |
| Last modified on | 2023/12/06 09:41:10 |
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Basic information
Public title
Observation study of continuous glucose monitoring for postoperative patients in esophageal cancer
Acronym
The continuous glucose monitoring for postoperative patients in esophageal cancer
Scientific Title
Observation study of continuous glucose monitoring for postoperative patients in esophageal cancer
Scientific Title:Acronym
The continuous glucose monitoring for postoperative patients in esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate postoperative changes in blood glucose levels in patients who have undergone radical surgery for esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
14-day continuous glucose monitoring
Key secondary outcomes
5-day dietary and symptom recording
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed as esophageal cancer.
2) Radical resection has been performed.
3) The surgical procedure (thoracotomy, thoracoscope, robot-assisted surgery, etc.) does not matter.
4) More than 3 months have passed since the esophagectomy, and the weight loss has subsided by oral intakes.
5) Stage I-IVA (resectable).
6) The age at the time of registration.
7) Gender does not matter.
8) PS: ECOG performance status score 0-1.
9) Patients who fill out the survey form.
10) Written consent has been obtained from the patient for participation in the study.
Key exclusion criteria
1) Patients who had not radical surgery.
2) Salvage surgery case.
3) During the other anti-cancer treatment (chemotherapy, radiation therapy, etc.).
4) Diabetes is being treated with oral hypoglycemic agents and insulin (perioperative insulin administration is acceptable).
5) Enteral nutritional supplements and other dietary supplements are also used.
6) There are some pathological conditions that the investigator deems inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0374
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
mniihara@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Niihara |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0374
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
mniihara@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine Clinical Research Ethics Committee
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
042-778-8273
rinrib@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050367
